Effect of 24 Months of Teriparatide Therapy on Bone Microarchitecture and Bone Volume in Men and Women With Osteoporosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Teriparatide (PTH) is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using a bone mineral density (BMD) scan, which measures the amount of mineral (calcium etc) in bones (the higher the amount of mineral, the lower the fracture risk). Although BMD is linked to bone strength and is used to measure fracture risk, it does not give information on bone structure (called bone geometry) which can also tell us a great deal about fracture risks. Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip, while BMD at the forearm may decrease after 20 months of therapy. However, bone biopsies of the pelvis done on people taking teriparatide show improvement of bone geometry (ie bone thickness and increased trabeculae (small interconnecting rods of bone), suggesting that a change in bone geometry at the wrist may be occurring as well. Currently, there is a new technology, high resolution pQCT (HR-pQCT) that can assess bone geometry without a biopsy. Since bone strength is affected both by BMD and bone structure (as well as other material properties), our group is interested in examining changes in bone geometry at the radius and tibia in men and women with osteoporosis who receives 24 months of teriparatide therapy. The investigators believe that this new approach of measuring bone strength will help us better understand the mechanisms of therapeutic efficacy of teriparatide. In addition, measuring indices of bone strength such as the material composition (bone mineral content or BMD) and structural properties of bone (size and shape, and microarchitecture) may provide more data about the mechanisms of how teriparatide treatment can decrease fracture risk. In the end, this data will benefit and improve patient care by allowing us to show patients and their providers that whether BMD increases, decreases or stay the same, there are changes in their bone geometric structure with teriparatide therapy that increases bone strength.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• History of fragility fracture OR

• High risk for fractures OR

• Very low BMD (T-score ≤ -2.5) OR

• Failed or intolerant to bisphosphonates

• Baseline serum levels of calcium, urate, ALP, PTH, creatinine and 25- hydroxyvitamin D \[25(OH)D\] must be within acceptable normal limits

• Ability to obtain teriparatide (not supplied by study sponsor)

Locations
Other Locations
Canada
University Health Network, TGH
RECRUITING
Toronto
Contact Information
Primary
Jessica Chang, RN
jessica.chang@uhn.on.ca
416-340-4800
Backup
Judite Scher, MSc CCRP
jscher@uhnresearch.ca
416-340-4841
Time Frame
Start Date: 2004-11
Estimated Completion Date: 2026-01
Participants
Target number of participants: 100
Treatments
Forteo (teriparatide)
postmenopausal women and men with osteoporosis Teriparatide is marketed as Forteo by Eli Lilly Teriparatide is not supplied (observational study)
Forteo (teriparatide) in AFF
women who have experienced an atypical femur fracture (AFF) Teriparatide is not supplied (observational study)
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov